Medical leads with frequency independent magnetic resonance imaging protection

ABSTRACT

A medical device having a frequency independent circuit that substantially reduces induced currents in a lead assembly and at a tissue interface. The frequency independent circuit configures an electrical path such that a stimulation pulse travels from the medical device to a selected tissue, and a current induced by an external changing electromagnetic signal is prevented from travelling the electrical path from the selected tissue to the medical device.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 60/869,507 filed Dec. 11, 2006.

FIELD OF THE PRESENT INVENTION

The present invention is directed to a device for protecting a patient,physician, and/or electronic components in an electrical deviceimplanted or partially implanted within the patient. More particularly,the present invention is directed to a device for protecting theconductive parts of the electrical device from current and voltagesurges induced by magnetic resonance imaging systems' oscillatingmagnetic fields.

BACKGROUND OF THE PRESENT INVENTION

Magnetic resonance imaging has been developed as an imaging techniqueadapted to obtain both images of anatomical features of human patientsas well as some aspects of the functional activities and characteristicsof biological tissue. These images have medical diagnostic value indetermining the state of the health of the tissue examined. Unlike thesituation with fluoroscopic imaging, a patient undergoing magneticresonance imaging procedure may remain in the active imaging system fora significant amount of time, e.g. a half-hour or more, withoutsuffering any adverse effects.

In a magnetic-resonance imaging process, a patient is typically alignedto place the portion of the patient's anatomy to be examined in theimaging volume of the magnetic-resonance imaging apparatus. Such anmagnetic resonance imaging apparatus typically comprises a primaryelectromagnet for supplying a constant magnetic field (B0) which, byconvention, is along the z-axis and is substantially homogeneous overthe imaging volume and secondary electromagnets that can provide linearmagnetic field gradients along each of three principal Cartesian axes inspace (generally x, y, and z, or x1, x2 and x3, respectively). Themagnetic-resonance imaging apparatus also comprises one or more RF(radio frequency) coils that provide excitation and detection of themagnetic-resonance imaging induced signals in the patient's body.

The gradient fields are switched ON and OFF at different rates dependingon the magnetic-resonance imaging scan sequence used. In some cases,this may result in a changing magnetic field on the order of dB/dt=50T/s. The frequency that a gradient field may be turned ON can be between200 Hz to about 300 kHz.

For a single loop with a fixed area, Lenz's law can be stated as:EMF=−A@dB/dt

where A is the area vector, B is the magnetic field vector, and “1” isthe vector scalar product. This equation indicates that anelectro-motive-force (EMF) is developed in any loop that encircles achanging magnetic field.

In a magnetic-resonance imaging system, there is applied to thebiological sample (patient) a switched gradient field in all 3coordinate directions (x-, y-, z-directions). If the patient has animplanted heart pacemaker (or other implanted devices having conductivecomponents) the switched gradient magnetic fields (an alternatingmagnetic field) may cause:

1. Erroneous signals to be induced/generated in a sensing lead or deviceor circuit;

2. Damage to electronics; and/or

3. Harmful stimulation of tissue, e.g. heart muscle, nerves, etc.

As noted above, the use of the magnetic-resonance imaging process withpatients who have implanted medical assist devices; such as cardiacassist devices or implanted insulin pumps; often presents problems. Asis known to those skilled in the art, implantable devices (such asimplantable pulse generators (IPGs) andcardioverter/defibrillator/pacemakers (CDPs)) are sensitive to a varietyof forms of electromagnetic interference (EMI) because these enumerateddevices include sensing and logic systems that respond to low-levelelectrical signals emanating from the monitored tissue region of thepatient. Since the sensing systems and conductive elements of theseimplantable devices are responsive to changes in local electromagneticfields, the implanted devices are vulnerable to external sources ofsevere electromagnetic noise, and in particular, to electromagneticfields emitted during the magnetic resonance imaging (magnetic-resonanceimaging) procedure. Thus, patients with implantable devices aregenerally advised not to undergo magnetic resonance imaging(magnetic-resonance imaging) procedures.

To more appreciate the problem, the use of implantable cardiac assistdevices during a magnetic-resonance imaging process will be brieflydiscussed.

The human heart may suffer from two classes of rhythmic disorders orarrhythmias: bradycardia and tachyarrhythmia. Bradycardia occurs whenthe heart beats too slowly, and may be treated by a common implantablepacemaker delivering low voltage (about 3 Volts) pacing pulses.

The common implantable pacemaker is usually contained within ahermetically sealed enclosure, in order to protect the operationalcomponents of the device from the harsh environment of the body, as wellas to protect the body from the device.

The common implantable pacemaker operates in conjunction with one ormore electrically conductive leads, adapted to conduct electricalstimulating pulses to sites within the patient's heart, and tocommunicate sensed signals from those sites back to the implanteddevice.

Furthermore, the common implantable pacemaker typically has a metal caseand a connector block mounted to the metal case that includesreceptacles for leads which may be used for electrical stimulation orwhich may be used for sensing of physiological signals. The battery andthe circuitry associated with the common implantable pacemaker arehermetically sealed within the case. Electrical interfaces are employedto connect the leads outside the metal case with the medical devicecircuitry and the battery inside the metal case.

Electrical interfaces serve the purpose of providing an electricalcircuit path extending from the interior of a hermetically sealed metalcase to an external point outside the case while maintaining thehermetic seal of the case. A conductive path is provided through theinterface by a conductive pin that is electrically insulated from thecase itself.

Such interfaces typically include a ferrule that permits attachment ofthe interface to the case, the conductive pin, and a hermetic glass orceramic seal that supports the pin within the ferrule and isolates thepin from the metal case.

A common implantable pacemaker can, under some circumstances, besusceptible to electrical interference such that the desiredfunctionality of the pacemaker is impaired. For example, commonimplantable pacemaker requires protection against electricalinterference from electromagnetic interference (EMI), defibrillationpulses, electrostatic discharge, or other generally large voltages orcurrents generated by other devices external to the medical device. Asnoted above, more recently, it has become crucial that cardiac assistsystems be protected from magnetic-resonance imaging sources.

Such electrical interference can damage the circuitry of the cardiacassist systems or cause interference in the proper operation orfunctionality of the cardiac assist systems. For example, damage mayoccur due to high voltages or excessive currents introduced into thecardiac assist system.

Moreover, problems are realized when the placement of the implant isnext to particular organs. For example, when a pacemaker is placed inthe upper chest and the lead tip is placed into the heart, a loop (anelectrical loop) is created. A changing magnetic field (the switchedgradient field) over the area of the loop (through the area of the loop)will cause an induced voltage (and current) across the heart. Thisinduced voltage (current) can stimulate the heart inappropriately andcan cause heart damage or death.

Therefore, it is desirable to provide a medical device or system thatreduces or eliminates the undesirable effects of changing magneticfields from a magnetic-resonance imaging system on the medical devicesand/or patients undergoing medical procedures or that have temporary orpermanent implanted materials and/or devices with conducting components.

SUMMARY OF THE PRESENT INVENTION

A first aspect of the present invention is a voltage compensation unitfor reducing the effects of induced voltages upon a device to a safelevel. The voltage compensation unit includes a sensing circuit to sensevoltages induced in conductive components of the device, the voltagesbeing induced by changing magnetic fields and a compensation circuit,operatively connected to the sensing circuit and responsive thereto, toprovide opposing voltages to the device to reduce the effects of inducedvoltages caused by changing magnetic fields.

A second aspect of the present invention is a voltage compensation unitfor reducing the effects of induced voltages upon a tissue invasivemedical tool to a safe level. The voltage compensation unit includes asensing circuit to sense voltages induced in conductive components ofthe medical tool, the voltages being induced by changing magneticfields; a compensation circuit, operatively connected to the sensingcircuit and responsive thereto, to provide opposing voltages to themedical tool to reduce the effects of induced voltages caused bychanging magnetic fields; and a connection device to provide anelectrical connection between the sensing circuit and the compensationcircuit and the medical tool.

A third aspect of the present invention is a voltage compensation unitfor reducing the effects of induced voltages upon a device to a safelevel. The voltage compensation unit includes a communication circuit,communicatively linked to a magnetic-resonance imaging system, toreceive information associated with a start and end of an application ofchanging magnetic fields produced by the magnetic-resonance imagingsystem and a compensation circuit, operatively connected to thecommunication circuit and responsive thereto, to synchronize applicationof opposing voltages to the device with the sensed changing magneticfields, the opposing voltages reducing the effects of induced voltagescaused by the changing magnetic fields.

A fourth aspect of the present invention is a voltage compensation unitfor reducing the effects of induced voltages upon a device to a safelevel. The voltage compensation unit includes a communication circuit,communicatively linked to a magnetic-resonance imaging system, toreceive information associated with a start and end of an application ofchanging magnetic fields produced by the magnetic-resonance imagingsystem and a compensation circuit, operatively connected to thecommunication circuit and responsive thereto, to apply opposing voltagesto the device, the opposing voltages reducing the effects of inducedvoltages caused by the changing magnetic fields.

A fifth aspect of the present invention is a voltage compensation unitfor reducing the effects of induced voltages upon a device having asingle wire line, the single wire line having a balanced characteristicimpedance. The voltage compensation unit includes a tunable compensationcircuit, operatively connected to the wire line, to apply supplementalimpedance to the wire line, the supplemental impedance causing thecharacteristic impedance of the wire line to become unbalanced, therebyreducing the effects of induced voltages caused by changing magneticfields.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region and a coil that generates a voltage due to achanging magnetic-resonance imaging electromagnetic field opposite tothat which would be induced by the changing magnetic-resonance imagingelectromagnetic field in the medical device electrical lead so as toreduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region and a plurality of coils, each coilgenerating a voltage due to a changing magnetic-resonance imagingelectromagnetic field such that a combination of voltages due to achanging magnetic-resonance imaging electromagnetic field provides acombined voltage that is opposite to the voltage which would be inducedby the changing magnetic-resonance imaging electromagnetic field in themedical device electrical lead so as to reduce voltages induced by thechanging magnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region and three orthogonally planar coils, eachcoil generating a voltage due to a changing magnetic-resonance imagingelectromagnetic field such that a combination of voltages due to achanging magnetic-resonance imaging electromagnetic field provides acombined voltage that is opposite to the voltage which would be inducedby the changing magnetic-resonance imaging electromagnetic field in themedical device electrical lead so as to reduce voltages induced by thechanging magnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region; a plurality of coils, each coil generating avoltage due to a changing magnetic resonance imaging electromagneticfield; a sensor to measure a strength of voltages induced by thechanging magnetic-resonance imaging electromagnetic field; and aswitching device, operatively connected to the sensor and plurality ofcoils, to operatively connect a number of the plurality of coils inresponse to the measured strength of voltages induced by the changingmagnetic-resonance imaging electromagnetic field such that a combinationof voltages due to a changing magnetic-resonance imaging electromagneticfield provides a combined voltage that is opposite to the voltage whichwould be induced by the changing magnetic-resonance imagingelectromagnetic field in the medical device electrical lead so as toreduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region; three orthogonally planar coils, each coilgenerating a voltage due to a changing magnetic-resonance imagingelectromagnetic field; a sensor to measure a strength of voltagesinduced by the changing magnetic-resonance imaging electromagneticfield; and a switching device, operatively connected to the sensor andthe coils, to operatively connect a number of the coils in response tothe measured strength of voltages induced by the changingmagnetic-resonance imaging electromagnetic field such that a combinationof voltages due to a changing magnetic-resonance imaging electromagneticfield provides a combined voltage that is opposite to the voltage whichwould be induced by the changing magnetic-resonance imagingelectromagnetic field in the medical device electrical lead so as toreduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region; a plurality of coils, each coil generating avoltage due to a changing magnetic resonance imaging electromagneticfield; a transceiver to receive a signal indicating a number of coils tobe connected; and a switching device, operatively connected to thetransceiver and plurality of coils, to operatively connect a number ofthe plurality of coils in response to the received signal indicating thenumber of coils to be connected such that a combination of voltages dueto a changing magnetic-resonance imaging electromagnetic field providesa combined voltage that is opposite to the voltage which would beinduced by the changing magnetic-resonance imaging electromagnetic fieldin the medical device electrical lead so as to reduce voltages inducedby the changing magnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region; three orthogonally planar coils, each coilgenerating a voltage due to a changing magnetic-resonance imagingelectromagnetic field; a transceiver to receive a signal indicating anumber of coils to be connected; and a switching device, operativelyconnected to the transceiver and the coils, to operatively connect anumber of the coils in response to the received signal indicating thenumber of coils to be connected such that a combination of voltages dueto a changing magnetic-resonance imaging electromagnetic field providesa combined voltage that is opposite to the voltage which would beinduced by the changing magnetic resonance imaging electromagnetic fieldin the medical device electrical lead so as to reduce voltages inducedby the changing magnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region and a coil thatgenerates a voltage induced by a changing magnetic-resonance imagingelectromagnetic field opposite to a voltage which would be induced bythe changing magnetic resonance imaging electromagnetic field in themedical device so as to reduce voltages induced by the changingmagnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region and a pluralityof coils, each coil generating a voltage due to a changingmagnetic-resonance imaging electromagnetic field such that a combinationof voltages due to a changing magnetic-resonance imaging electromagneticfield provides a combined voltage that is opposite to the voltage whichwould be induced by the changing magnetic resonance imagingelectromagnetic field in the medical device so as to reduce voltagesinduced by the changing magnetic-resonance imaging electromagneticfield.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region and threeorthogonally planar coils, each coil generating a voltage due to achanging magnetic resonance imaging electromagnetic field such that acombination of voltages due to a changing magnetic-resonance imagingelectromagnetic field provides a combined voltage that is opposite tothe voltage which would be induced by the changing magnetic-resonanceimaging electromagnetic field in the medical device so as to reducevoltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region; a plurality ofcoils, each coil generating a voltage due to a changingmagnetic-resonance imaging electromagnetic field; a sensor to measure astrength of voltages induced by the changing magnetic-resonance imagingelectromagnetic field; and a switching device, operatively connected tothe sensor and plurality of coils, to operatively connect a number ofthe plurality of coils in response to the measured strength of voltagesinduced by the changing magnetic-resonance imaging electromagnetic fieldsuch that a combination of voltages due to a changing magnetic-resonanceimaging electromagnetic field provides a combined voltage that isopposite to the voltage which would be induced by the changingmagnetic-resonance imaging electromagnetic field in the medical deviceso as to reduce voltages induced by the changing magnetic-resonanceimaging electromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region; threeorthogonally planar coil, each coil generating a voltage due to achanging magnetic-resonance imaging electromagnetic field; a sensor tomeasure a strength of voltages induced by the changingmagnetic-resonance imaging electromagnetic field; and a switchingdevice, operatively connected to the sensor and plurality of coils, tooperatively connect a number of the plurality of coils in response tothe measured strength of voltages induced by changing magnetic-resonanceimaging electromagnetic field such that a combination of voltages due toa changing magnetic-resonance imaging electromagnetic field provides acombined voltage that is opposite to the voltage which would be inducedby the changing magnetic resonance imaging electromagnetic field in themedical device so as to reduce voltages induced by the changingmagnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region; a plurality ofcoils, each coil generating a voltage due to a changingmagnetic-resonance imaging electromagnetic field; a transceiver toreceive a signal indicating a number of coils to be connected; and aswitching device, operatively connected to the transceiver and thecoils, to operatively connect a number of the coils in response to thereceived signal indicating the number of coils to be connected such thata combination of voltages due to a changing magnetic-resonance imagingelectromagnetic field provides a combined voltage that is opposite tothe voltage which would be induced by the changing magnetic-resonanceimaging electromagnetic field in the medical device so as to reducevoltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region; threeorthogonally planar coil, each coil generating a voltage due to achanging magnetic-resonance

imaging electromagnetic field; a transceiver to receive a signalindicating a number of coils to be connected; and a switching device,operatively connected to the transceiver and the coils, to operativelyconnect a number of the coils in response to the received signalindicating the number of coils to be connected such that a combinationof voltages due to a changing magnetic-resonance imaging electromagneticfield provides a combined voltage that is opposite to the voltage whichwould be induced by the changing magnetic-resonance imagingelectromagnetic field in the medical device so as to reduce voltagesinduced by the changing magnetic-resonance imaging electromagneticfield.

Another aspect of the present invention is an electrical lead componentfor a medical device which reduces the effects of magnetic-resonanceimaging induced signals. The electrical lead component includes amedical device electrical lead capable of providing an electrical pathto a desired tissue region; a voltage source; a sensor to sense voltagesinduced by the changing magnetic resonance imaging electromagneticfield; and a switching device, operatively connected to the sensor andvoltage source, to operatively connect the voltage source to the medicaldevice electrical lead in response to the sensed voltage induced by thechanging magnetic-resonance imaging electromagnetic field such that thevoltage source provides a voltage that is opposite to the voltage whichwould be induced by the changing magnetic-resonance imagingelectromagnetic field in the medical device electrical lead so as toreduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is a medical device for amedical device which reduces the effects of magnetic-resonance imaginginduced signals. The medical device includes a medical device capable ofproviding medical treatment to a desired tissue region; a voltagesource; a sensor to sense voltages induced by the changingmagnetic-resonance imaging electromagnetic field; and a switchingdevice, operatively connected to the sensor and voltage source, tooperatively connect the voltage source to the medical device in responseto the sensed voltage induced by the changing magnetic-resonance imagingelectromagnetic field such that the voltage source provides a voltagethat is opposite to the voltage which would be induced by the changingmagnetic-resonance imaging electromagnetic field in the medical deviceso as to reduce voltages induced by the changing magnetic-resonanceimaging electromagnetic field.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes two coiled conductive strands forminga spring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strands and an insulating coating formed over a portion ofthe two coiled conductive strands such that an inline inductive elementis formed, the current flowing along a curvature of the two coiledconductive strands in the insulating coated portion of the two coiledconductive strands.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes two coiled conductive strands forminga spring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strands and an adjustable resistive material formed over aportion of the two coiled conductive strands such that an inlineinductive element is formed, the current flowing along a curvature ofthe two coiled conductive strands in the adjustable resistive materialportion of the two coiled conductive strands.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes a coiled conductive strand forming aspring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strand and an insulating coating formed over a portion of thecoiled conductive strand such that an inline inductive element isformed, the current flowing along a curvature of the coiled conductivestrand in the insulating coated portion of the coiled conductive strand.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes a coiled conductive strand forming aspring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strand and an adjustable resistive material formed over aportion of the coiled conductive strand such that an inline inductiveelement is formed, the current flowing along a curvature of the coiledconductive strand in the adjustable resistive material portion of thecoiled conductive strand.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes two coiled conductive strands forminga spring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strands; a first insulating coating formed over a firstportion of the two coiled conductive strands such that a first inlineinductive element having a first inductance is formed, the currentflowing along a curvature of the two coiled conductive strands in thefirst insulating coated portion of two coiled conductive strands; and asecond insulating coating formed over a second portion of the two coiledconductive strands such that a second inline inductive element having asecond inductance is formed, the current flowing along a curvature ofthe two coiled conductive strands in the second insulating coatedportion of two coiled conductive strands. The first inductance isdifferent from the second inductance.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes two coiled conductive strands forminga spring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strands; a first adjustable resistive material formed over afirst portion of the two coiled conductive strands such that a firstinline inductive element having a first inductance is formed, thecurrent flowing along a curvature of the two coiled conductive strandsin the first adjustable resistive material portion of the two coiledconductive strands; and a second adjustable resistive material formedover a second portion of the two coiled conductive strands such that asecond inline inductive element having a second inductance is formed,the current flowing along a curvature of the two coiled conductivestrands in the second adjustable resistive material portion of the twocoiled conductive strands. The first inductance is different from thesecond inductance.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes a coiled conductive strand forming aspring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strand; a first insulating coating formed over a firstportion of the coiled conductive strand such that a first inlineinductive element having a first inductance is formed, the currentflowing along a curvature of the coiled conductive strand in the firstinsulating coated portion of the coiled conductive strand; and a secondinsulating coating formed over a second portion of the coiled conductivestrand such that a second inline inductive element having a secondinductance is formed, the current flowing along a curvature of thecoiled conductive strand in the second insulating coated portion of thecoiled conductive strand. The first inductance is different from thesecond inductance.

Another aspect of the present invention is a lead for medicalapplications that reduces the effects of magnetic-resonance imaginginduced signals. The lead includes a coiled conductive strand forming aspring-like configuration such that current flows over a surfacethereof, through contact points between adjacent loops of the coiledconductive strand; a first adjustable resistive material formed over afirst portion of the coiled conductive strand such that a first inlineinductive element having a first inductance is formed, the currentflowing along a curvature of the coiled conductive strand in the firstadjustable resistive material portion of the coiled conductive strand;and a second adjustable resistive material formed over a second portionof the coiled conductive strand such that a second inline inductiveelement having a second inductance is formed, the current flowing alonga curvature of the coiled conductive strand in the second adjustableresistive material portion of the coiled conductive strand. The firstinductance is different from the second inductance.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including a coil that generates avoltage due to a changing magnetic-resonance imaging electromagneticfield opposite to that which would be induced by the changingmagnetic-resonance imaging electromagnetic field in the electrical leadwithout the coil so as to reduce voltages induced by the changingmagnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including a plurality of coils, atleast one coil generating a voltage due to a changing magnetic-resonanceimaging electromagnetic field such that a combination of voltages due toa changing magnetic-resonance imaging electromagnetic field provides acombined voltage that is opposite to the voltage which would be inducedby the changing magnetic-resonance imaging electromagnetic field in theelectrical lead without the plurality of coils so as to reduce voltagesinduced by the changing magnetic-resonance imaging electromagneticfield.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including planar coils, at least onecoil generating a voltage due to a changing magnetic-resonance imagingelectromagnetic field such that a combination of voltages due to achanging magnetic-resonance imaging electromagnetic field provides acombined voltage that is opposite to the voltage which would be inducedby the changing magnetic-resonance imaging electromagnetic field in theelectrical lead without the planar coils so as to reduce voltagesinduced by the changing magnetic-resonance imaging electromagneticfield.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including a plurality of coils, atleast one coil generating a voltage due to a changing magnetic-resonanceimaging electromagnetic field; a sensor to measure a strength ofvoltages induced by the changing magnetic resonance imagingelectromagnetic field; and a switching device, operatively connected tothe sensor and plurality of coils, to operatively connect a number ofthe plurality of coils in response to the measured strength of voltagesinduced by the changing magnetic-resonance imaging electromagnetic fieldsuch that a combination of voltages due to a changing magnetic-resonanceimaging electromagnetic field provides a combined voltage that isopposite to the voltage which would be induced by the changingmagnetic-resonance imaging electromagnetic field in the electrical leadwithout the coils so as to reduce voltages induced by the changingmagnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including planar coils, at least onecoil generating a voltage due to a changing magnetic-resonance imagingelectromagnetic field; a sensor to measure a strength of voltagesinduced by the changing magnetic-resonance imaging electromagneticfield; and a switching device, operatively connected to the sensor andthe coils, to operatively connect a number of the coils in response tothe measured strength of voltages induced by the changing magneticresonance imaging electromagnetic field such that a combination ofvoltages due to a changing magnetic-resonance imaging electromagneticfield provides a combined voltage that is opposite to the voltage whichwould be induced by the changing magnetic-resonance imagingelectromagnetic field in the electrical lead without the planar coils soas to reduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including a plurality of coils, atleast one coil generating a voltage due to a changing magnetic-resonanceimaging electromagnetic field; a transceiver to receive a signalindicating a number of coils to be connected; and a switching device,operatively connected to the transceiver and plurality of coils, tooperatively connect a number of the plurality of coils in response tothe received signal indicating the number of coils to be connected suchthat a combination of voltages due to a changing magnetic-resonanceimaging electromagnetic field provides a combined voltage that isopposite to the voltage which would be induced by the changingmagnetic-resonance imaging electromagnetic field in the electrical leadwithout the coils so as to reduce voltages induced by the changingmagnetic-resonance imaging electromagnetic field.

Another aspect of the present invention is an electrical lead for amedical device, the electrical lead capable of providing an electricalpath to a desired tissue region, including planar coils, at least onecoil generating a voltage due to a changing magnetic-resonance imagingelectromagnetic field; a transceiver to receive a signal indicating anumber of coils to be connected; and a switching device, operativelyconnected to the transceiver and the coils, to operatively connect anumber of the coils in response to the received signal indicating thenumber of coils to be connected such that a combination of voltages dueto a changing magnetic-resonance imaging electromagnetic field providesa combined voltage that is opposite to the voltage which would beinduced by the changing magnetic-resonance imaging electromagnetic fieldin the medical device electrical lead without the planar coils so as toreduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a RF choke, operatively connected to theelectrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The RF choke allows a signal corresponding to ameasured characteristic of the tissue region to pass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a RF filter, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The RF filter allows a signal corresponding to ameasured characteristic of the tissue region to pass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a notch filter, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The notch filter allows a signal corresponding to ameasured characteristic of the tissue region to pass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a bandpass filter, operatively connectedto the electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The band pass filter allows a signal corresponding toa measured characteristic of the tissue region to pass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and an inductor, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The inductor allows a signal corresponding to ameasured characteristic of the tissue region to pass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a RF choke, operatively connected to theelectrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The RF choke allows a therapeutic signal to passtherethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a RF filter, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The RF filter allows a therapeutic signal to passtherethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a notch filter, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The notch filter allows a therapeutic signal to passtherethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a bandpass filter, operatively connectedto the electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The bandpass filter allows a therapeutic signal topass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and an inductor, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The inductor allows a therapeutic signal to passtherethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a tank circuit, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The tank circuit allows a signal corresponding to ameasured characteristic of the tissue region to pass therethrough.

Another aspect of the present invention is an electrical lead includingan electrical strand to provide an electrical path between a tissueregion and a medical device and a tank circuit, operatively connected tothe electrical strand, to significantly reduce currents induced by achanging magnetic resonance imaging electromagnetic field in theelectrical strand. The tank circuit allows a therapeutic signal to passtherethrough.

Another aspect of the present invention is an adapter for a medicaldevice which reduces the effects of magnetic-resonance imaging inducedsignals. The adapter includes a port to receive a medical deviceelectrical lead capable of providing an electrical path to a desiredtissue region; a plurality of coils, each coil generating a voltage dueto a changing magnetic-resonance imaging electromagnetic field; theplurality of coils, due to a changing magnetic resonance imagingelectromagnetic field, providing a combined voltage that is opposite tothe voltage which would be induced by the changing magnetic resonanceimaging electromagnetic field in the medical device electrical lead soas to reduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field.

Another aspect of the present invention is an adapter for a medicaldevice which reduces the effects of magnetic-resonance imaging inducedsignals. The adapter includes a port to receive a medical deviceelectrical lead capable of providing an electrical path to a desiredtissue region; a coil, the coil generating a voltage due to a changingmagnetic-resonance imaging electromagnetic field; the coil, due to achanging magnetic-resonance imaging electromagnetic field, providing avoltage that is opposite to the voltage which would be induced by thechanging magnetic-resonance imaging electromagnetic field in the medicaldevice electrical lead so as to reduce voltages induced by the changingmagnetic-resonance imaging electromagnetic field.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may take form in various components andarrangements of components, and in various steps and arrangements ofsteps. The drawings are only for purposes of illustrating a preferredembodiment and are not to be construed as limiting the presentinvention, wherein:

FIG. 1 is a schematic of an implanted pacemaker arrangement in a body;

FIG. 2 is a schematic of a pacemaker lead comprising three conductivestrands;

FIG. 3 is a schematic of a sensing system used with a pacemaker;

FIG. 4 illustrates an embodiment of a pacemaker canister according tothe concepts of the present invention;

FIG. 5 illustrates another embodiment of a pacemaker canister accordingto the concepts of the present invention;

FIG. 6 illustrates a further embodiment of a pacemaker canisteraccording to the concepts of the present invention;

FIG. 7 is an illustration of inductive currents in conductor loops;

FIG. 8 is an illustration of canceling inductive currents in conductorloops according to the concepts of the present invention;

FIG. 9 is a schematic of an embodiment of a pacemaker lead utilizinginductive loops according to the concepts of the present invention;

FIG. 10 is a schematic of an embodiment of inductive loops in apacemaker canister according to the concepts of the present invention;

FIG. 11 is a schematic of an embodiment of inductive loops around apacemaker canister according to the concepts of the present invention;

FIG. 12 illustrates of an embodiment of a medical device with anexternal voltage cancellation unit according to the concepts of thepresent invention;

FIG. 13 illustrates of another embodiment of a medical device with anexternal voltage cancellation unit according to the concepts of thepresent invention;

FIG. 14 illustrates a portion of coiled leads used in a medial deviceaccording to the concepts of the present invention;

FIG. 15 illustrates another embodiment of a portion of coiled leads usedin a medial device according to the concepts of the present invention;

FIG. 16 illustrates a further embodiment of a portion of coiled leadsused in a medial device according to the concepts of the presentinvention;

FIG. 17 illustrates another embodiment of a portion of coiled leads usedin a medial device according to the concepts of the present invention;

FIG. 18 illustrates a circuit diagram representing a guide wire with anunbalancing impedance circuit according to the concepts of the presentinvention;

FIG. 19 illustrates another embodiment of a circuit diagram representinga guide wire with an unbalancing impedance circuit according to theconcepts of the present invention;

FIG. 20 illustrates a balun used in conjunction with a guide wireaccording to the concepts of the present invention;

FIG. 21 is a circuit diagram representing a capacitance unbalanced balununit according to the concepts of the present invention;

FIG. 22 illustrates an implantable therapeutic system;

FIG. 23 illustrates a schematic of an implantable therapeutic system;

FIG. 24 illustrates another implantable therapeutic system;

FIG. 25 is a graph of one potential type of therapeutic voltage pulse;

FIG. 26 is a graph of a diode's Current versus Voltage performance;

FIG. 27 illustrates another implantable therapeutic system;

FIG. 28 illustrates another implantable therapeutic system;

FIG. 29 illustrates a simulation of an implantable therapeutic system;

FIG. 30 illustrates another simulation of an implantable therapeuticsystem;

FIG. 31 illustrates another simulation of an implantable therapeuticsystem;

FIG. 32 illustrates another simulation of an implantable therapeuticsystem;

FIG. 33 illustrates another simulation of an implantable therapeuticsystem;

FIG. 34 illustrates another simulation of an implantable therapeuticsystem;

FIG. 35 illustrates another simulation of an implantable therapeuticsystem; and

FIG. 36 illustrates another simulation of an implantable therapeuticsystem.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The present invention will be described in connection with preferredembodiments; however, it will be understood that there is no intent tolimit the present invention to the embodiments described herein. On thecontrary, the intent is to cover all alternatives, modifications, andequivalents as may be included within the spirit and scope of thepresent invention as defined by the appended claims.

For a general understanding of the present invention, reference is madeto the drawings. In the drawings, like reference have been usedthroughout to designate identical or equivalent elements. It is alsonoted that the various drawings illustrating the present invention arenot drawn to scale and that certain regions have been purposely drawndisproportionately so that the features and concepts of the presentinvention could be properly illustrated.

FIG. 1 is a schematic showing a typical pacemaker arrangement 100. Thepacemaker comprises a pulse generator canister 102 housing a powersupply (not shown) and electronic components (not shown) for sensing andproducing electrical pacing pulses. The pulse generator canister 102 hasconnected to it insulated conductive leads 104 that pass through thebody (not shown) and into the heart 106. Conventional bipolar pacemakerleads have two conductive strands, one for pacing and sensing, and theother for ground. The path of the leads 104 is generally not straight.The leads 104 have one or more electrodes 112 in contact with the heart106. The direct line 108 from the heart 106, where the electrodes 112are placed, to the generator canister 102 represents a conductive pathcomprising body tissue (not shown) and fluids (not shown). The completedloop from the pacemaker canister 102, through the leads 104, and back tothe pacemaker canister 102 along the path 108 is subject to Lenz's law.That is, a changing magnetic field 110 through the area enclosed by thecompleted loop (from the pacemaker canister 102, through the leads 104,and back to the pacemaker canister 102 along the path 108) can induceunwanted voltages in the leads 104 and across the heart 106.

In one embodiment of the present invention, and referring to FIG. 1, thepacemaker canister 102 is made out of a non-conductive material. Inanother embodiment, the canister 102 is coated or covered with variousnon-conductive insulating materials. This increases the overallresistance of the conductive path loop and thus reduces the voltageacross the tissue between electrodes 112 and the canister 102.

Using a three-strand lead design allows for the separation of the pacingsignals from the sensing signals and allows for different filteringtechniques to be utilized on each separate conductive strand: one strandfor the pacing signal for stimulating the heart, one conductive strandfor the sensing of the heart's electrical state, pre-pulse, ecg, etc.,and one strand for the ground path. Current bi-polar designs use onlytwo conductive strands. This means that the pacing and the sensingsignals are carried on the same strand.

For example, in conventional bipolar pacemaker leads, the pacing signalgoes “down” (from generator canister to heart) the pacing lead(conductive strand) while the sensing signal travels “up” (from heart togenerator canister) the pacing lead. This is the “standard” bipolarpacing setup. If a filter is added to the pacing/sensing strand to blockthe switch gradient induced signal caused by a magnetic-resonanceimaging system, the pacing pulse/signal must travel through the filter,thereby distorting the pacing pulse.

According to the concepts of the present invention, by adding a thirdconductive strand, a diode, for example, can be put on the pacing strandand one or more filters can be put on the sensing strand. The filters onthe sensing lead may be at the distal end of the pacemaker lead or inthe generator canister. Thus, by using separate strands, the presentinvention is able to utilize different kinds of filters (RF filters,high/low pass filters, notch filters, tank circuit, etc.) or otherelectronics in conjunction with each strand depending on the differentsignal characteristics and/or signal direction along the conductivestrand.

FIG. 2 shows a schematic of a pacemaker arrangement 120 including agenerator canister 122 containing a pacing pulse generator (not shown),sensing electronics (not shown) and other electronic components (notshown). Attached to the generator canister 122 is a lead assembly 140having three conductive strands 124, 126, and 128 through lumen 138.Each of the conductive strands 124, 126, and 128 pass through the distaltip 142 of the lead assembly 140 to exposed electrodes 132, 134, and136, respectively. The exposed electrodes 132, 134, and 136 are placedin contact with or next to the heart.

Conductive strand 124 and electrode 132 are used to deliver pulses tothe heart from a pacing generator within the canister 122. Conductivestrand 126 and electrode 134 are used as a ground. Conductive strand 128and electrode 136 are utilized for sensing the electrical signalsgenerated by the heart. In this way, the sensing functionality ofpacemakers can be separated from the delivery of pacing pulses.

To block any induced voltage signals from the magnetic-resonance imagingsystem's changing magnetic fields (the RF or the gradient fields) frompropagating along the conductive pulse delivery strand 124, a diode 130is inserted into the conductive strand 124 near the distal tip of thelead assembly 142. It is noted that the diode 130 can also be is placedin the generator canister 122.

With respect to FIG. 2, other electronic components (i.e. RF Chokes,notch filters, tank circuits, etc.) may be placed into the otherconductive strands 126 and 128 shown as by components 146 and 144,respectively. It is noted that a tank circuit is a parallel resonantcircuit containing only a coil and a capacitor wherein both the coil andcapacitor store electrical energy for part of each cycle. It is furthernoted that these optional electronic components 146 and 144 can beplaced in the generator canister 122.

Optional electronic components 146 and 144 are used to block orsignificantly reduce any unwanted induced signals caused by the magneticresonance imaging system from passing along conductive strands 126 and128 respectively while allowing the desired sensing signals from theheart to pass along conductive strand 126 to electronics in thegenerator canister 122.

FIG. 3 is a schematic of an embodiment of the present invention. Asillustrated in FIG. 3, a patient 162 is located within amagnetic-resonance imaging system 168, wherein the patient 162 has animplanted heart pacemaker pulse generator canister 164. A surfacesensor/transceiver 166 is placed on the exterior of the patient's body162 over or near the location of the implanted pacemaker generator 164.The sensor/transceiver 166 is in communication with themagnetic-resonance imaging system 168 via communication line 170, whichmay be a magnetic-resonance imaging safe cable such as a fiber opticalcable. Additionally, the sensor/transceiver 166 is in communication withthe implanted pacemaker pulse generator canister 164. The means ofcommunication between the sensor/transceiver 166 and the implantedpacemaker generator 164 may be acoustic, optical, or other means that donot interfere with the imaging capabilities or image quality of themagnetic-resonance imaging system. The signals may be digital or analog.

Moreover, with respect to this embodiment of the present invention, atransmitter/receiver is placed in the pacemaker canister 164 so that themagnetic-resonance imaging system 168 can be in operative communicationwith the pacemaker system and vice versa. Thus, the pacing system cantransmit signals to the magnetic-resonance imaging system 168 indicatingwhen the pacemaker is about to deliver a pacing pulse to the heart. Thetransmitted signals may be digital or analog. In response to thistransmitted signal, the magnetic-resonance imaging system 168 stops orpauses the magnetic resonance imaging switched gradient field (imagingscanning sequence) to allow the pacing pulse to occur. After the pacingpulse has been delivered to the heart, the magnetic-resonance imagingsystem 168 resumes or begins a new imaging scanning sequence.

In another mode of operation, the magnetic-resonance imaging system 168sends signals to the implanted heart pacemaker pulse generator canister164 through the sensor/transceiver 166 indicating the application ofswitched gradient fields. The pacemaker may use this information toswitch filters or other electronics in and out of the circuit to reduceor eliminate voltages induced in the pacemaker leads by the gradientfields. For example, the pacemaker may switch in additional resistanceor inductance or impedance into the pacing/sensing and/or ground strandsbased on the signal from the magnetic-resonance imaging system 168signifying the application of the gradient fields.

In another configuration, there is no surface sensor/transceiver orcommunication line to the magnetic-resonance imaging system 168.Instead, there is a special sensor in the implanted heart pacemakerpulse generator canister 164 that can sense the application of thegradient fields. In response thereof, the pacemaker switches into theelectrical circuit of the pacing/sense and/or ground leads a chargingsource which is used to charge the implanted heart pacemaker pulsegenerator canister 164, leads, and/or electrodes to an electricalpotential opposite to that which would be induced by the gradientfields. In this way, the induced voltages caused by the gradient fieldsare cancelled out or reduced to a safe level, by the application of thisvoltage source.

In a preferred embodiment of the present invention, the charging/voltagesource receives its power from inductively coupling to themagnetic-resonance imaging system's RF field. The oscillating RF fieldsupplies power to charge special capacitors in the implanted heartpacemaker pulse generator canister 164. It is noted that other externalpower sources can be used to power the charging/voltage source in theimplanted heart pacemaker pulse generator canister 164.

FIG. 4 is a diagram of an assembly 170 for the pacemaker generatorcomponents comprising the canister housing 172, a programmable logicunit (PLU) 184, a power source 174, and a pulse generator 176.Additionally, means for communicating with an externalsensor/transceiver is provided by transceiver 180. Other electroniccomponents 178; e.g., signal filters, signal processors, leadconnectors, etc. are also located in the canister 172. The pacing leads182 pass through the canister 172 and connect to the internalelectronics 178. During a magnetic-resonance imaging examination, thesignals transmitted and received by the transceiver 180 may be used tosynchronize the magnetic resonance imaging system's scanning sequenceswith the delivery of the pacing signals.

In another embodiment, as depicted in FIG. 5, the pacing generatorassembly 190 further includes a second power module 186 which may be aninductive coil and/or capacitor bank, suitable for capturing and storingpower from the magnetic-resonance imaging system's transmitted RFsignal.

In one embodiment, the power stored in the power module 186 is used todevelop an electrical potential in the leads 182 that is opposed to thatwhich is induced by the application of the magnetic-resonance imagingsystem's gradient fields.

FIG. 21 further illustrates a common-mode feedback circuit 400. Thecommon-mode feedback circuit is similar as those in conventional fullydifferential operational amplifiers. The common-mode amplifier 400amplifies the difference between the output common-mode voltage(voutp+voutn)/2 and the desired output common-mode voltage. The outputof the common-mode amplifier 400 provides negative feedback to controlsthe current sources 210 and 220 to keep the output common-mode voltageconstant.

Alternatively, the output of the common-mode amplifier 400 may controlthe current sources 230 and 240. The common-mode feedback can be engagedduring all or any of the segments. It is preferred that the common-modefeedback be engaged during the first segment only while keeping currentsource 220 constant and matched to current source 240.

In another embodiment, the power stored in the power module 186 is usedto operate various switches in the electronics module 178 which mayswitch in or out various power serge protection circuits in-line and/orsignal filters to the leads 182.

In a further embodiment, and referring to FIG. 5, the module 186 may beused to electrically charge the pacemaker canister 172, which is made ofa conductive material, in synchronization with the application of themagnetic resonance imaging system's gradient fields so that theelectrical potential difference between the pacing electrodes and thepacemaker canister 172 is reduced. That is, the sum of the inducedvoltage difference due to the application of the gradient fields plusthe voltage difference due to the application of the electrical chargestored in the power module 186 results is a net voltage significantlybelow any threshold level, above which a problem may develop.

FIG. 6 depicts another assembly 200, which includes the basic componentsof FIG. 5 less the transceiver 180, a gradient field detector 204, and aby-pass switch component 202. By detecting the gradient signal in thepacemaker canister 172 with gradient field detector 204, the pacemakercan switch filters and/or other electronics 178 in or out of thecircuit.

In one embodiment, when no gradient fields are detected, the switch 202is closed to by-pass the electronics component 178, which may be acombination of low-pass, high-pass, notch filters, diodes, and/or otherelectronics. In this mode (switched closed), the pacing pulse (andsensing signals) by-pass the filters components 178. When gradient fielddetector 204 detects the gradient signals, the switch 202 is opened andany gradient fields induced signals in the leads 182 are blocked orsignificantly reduced by the filters components 178. In the open mode,the pacing and sensing signals pass through the filters component 178 aswell.

The gradient detector 204 may communicate the sensing of the gradientfield to other components in the pacemaker via its connection to the PLU184 so that the pacing signal can be modified, if necessary, tocompensate for any distortion it may suffer by now going through thefilters component 178. Additionally, the sensing signal, now alsopassing through the filter components 178 may be distorted. This may becompensated for by including signal recovery/reconstruction logic intothe PLU or into a separate signal-processing component.

Referring back to FIG. 1, by increasing the impedance of the leads 104,the voltage across the tissue gap from the electrodes 112 and thepacemaker canister 102 can be reduced. Inserting a resistor or using ahigher resistive wire for the pacemaker leads 104 will reduce thecurrent induced in the current loop, which includes the virtual loopportion across the (heart 112) tissue to the pacemaker generatorcanister 102.

By using various inductors in-line with the various leads 104, it ispossible to make the leads 104 have a high impedance for the lowfrequency magnetic-resonance imaging gradient fields frequency and a lowimpedance for the magnetic-resonance imaging system's RF frequency.Alternatively, different impedances (inductors/resistors/capacitors) maybe switched in-line or out of the leads' circuitry depending on thetiming and application of the gradient and/or RF fields.

In another embodiment, not shown, the pacemakers' electronics can beaugmented to include one or more digital signal processors. Byconverting the sensing signal into a digital signal, the digital signalprocessor (DSP) can reconstruct the sensing signal after it has passedthrough filters and has been distorted by the filtering or otherelements that may have been added to the lead circuit. The DSP may alsobe used to reject any signals that do not have a correct cardiacsignature, thus rejecting any signals caused by the switched gradientfields, which is a non-cardiac signal.

In another embodiment of the present invention, a pacemaker lead orother medical device, having a long conductive lead and functioning inan magnetic-resonance imaging environment, may be configured, accordingto the concepts of the present invention, to include additional loops tocancel the induced voltage effects in the leads of the original currentloop formed by the leads.

In a further modification of the present invention (not shown), anelectrical lead component for a medical device includes an electricallead that provides an electrical path to a desired tissue region. Theelectrical lead component further includes a voltage source, such as abattery or capacitor and a sensor to sense voltages induced by thechanging magnetic-resonance imaging electromagnetic field. A switchingdevice, connected to the sensor and voltage source, connects the voltagesource to the electrical lead in response to the sensed voltage inducedby the changing magnetic-resonance imaging electromagnetic field suchthat the voltage source provides a voltage that is opposite to thevoltage which would be induced by the changing magnetic resonanceimaging electromagnetic field in the medical device electrical lead soas to reduce voltages induced by the changing magnetic-resonance imagingelectromagnetic field. The electrical lead component further includes avariable resistor connected to the voltage source to regulate an amountof voltage being provided. The changing magnetic-resonance imagingelectromagnetic field is a magnetic-resonance imaging switched gradientfield or a magnetic-resonance imaging switched gradient field.

Additionally, the present invention may be modified (not shown) so thata medical device that is capable of providing medical treatment to adesired tissue region is associated with a voltage source and a sensorto sense voltages induced by the changing magnetic-resonance imagingelectromagnetic field. A switching device, connected to the sensor andvoltage source, connects the voltage source to the medical device inresponse to the sensed voltage induced by the changingmagnetic-resonance imaging electromagnetic field such that the voltagesource provides a voltage that is opposite to the voltage which would beinduced by the changing magnetic-resonance imaging electromagnetic fieldin the medical device so as to reduce voltages induced by the changingmagnetic resonance imaging electromagnetic field. The medical device isfurther associated with a variable resistor connected to the voltagesource to regulate an amount of voltage being provided. The changingmagnetic-resonance imaging electromagnetic field is a magnetic-resonanceimaging switched gradient field or a magnetic-resonance imaging switchedgradient field.

In FIG. 7, two conductive loops 260 and 270 having the same amount ofarea and in the same plane, positioned in a changing magnetic field 262and 272, develop currents 264 and 274. In FIG. 7, both induced currentsI1 and I2 travel in the same direction (clockwise direction shown) atall times as the magnetic field 262 and 272 oscillate.

FIG. 8 shows that by connecting the two conductive loops 260 and 270 ofFIG. 7 to form a single conductor 280, the currents induced in each lobecan be made to cancel each other out. The two loops are connected sothat a single conductor is formed which crosses over itself at 284. Inthis case, as shown in FIG. 8, the two currents 286 and 288 cancel eachother out resulting in net current of zero magnitude around theconductor 280. This type of configuration of conductors in a changingmagnetic field may be used to cancel induced currents in the conductors.

FIG. 9 depicts an implanted pacemaker system 220 comprising a pacinggenerator canister 102, conductive leads 104, and electrodes 112positioned in the heart 106. Additional loops 222 are added to theoverall configuration of the lead 104 in the body with one or morecrossings 224. In accordance with the concepts of the present invention,the plane of the loop 222 is in the same plane as defined by the rest ofthe lead geometry.

The same oscillating magnetic field 110 passes through loop 222 and theloop defined by generator canister 102, conductive leads 104, electrodes112, and conductive path 108 through the body from the heart 106 to thegenerator canister 102. It is noted that the total area enclosed by theloops can be adjusted by adding or removing loops 222 or by changing thearea enclosed by the loops (singly or collectively).

In one embodiment, the total area of the loop 222 is the same as theloop area 226. In another embodiment, the total area of the loop 222 isdifferent from loop area 226. In another embodiment, the plane of loop222 is different from the plane of loop area 226. In yet anotherembodiment, loop 222 and/or loop area 226 do not define a single planebut are curved in three different spatial directions. In yet anotherembodiment, loop 222 consists of at least three loops in threeorthogonal planes.

In a further embodiment, as illustrated in FIG. 11 and will be discussedin more detail below, the new additional loops 222 can be positioned insuch a way as to encircle the pacemaker's generator canister 102. Inanother embodiment, as illustrated in FIG. 10 and will be discussed inmore detail below, the additional loops 222 may be positioned inside thepacemaker's generator canister 102.

Referring back to FIG. 9, a fastener (not shown) can be used at the loopcross over point 224 to allow for adjustment of the loop's enclosed areaand/or orientation and, once adjusted, to lock in the loop'sadjustments. This same fastener can also be used to adjust a pluralityof loops.

In another aspect of the present invention, a selection mechanism can beincluded in the pacemaker system. This selection mechanism is used toadjust the number of loops to include in the circuit.

For example, if the loops are located within the pacemaker canister, theselection mechanism can be used to manually select how many loops toinclude in the lead circuit depending on where the pacemaker can isplaced in the body and the length of the lead. Alternatively, theselection mechanism may be used to automatically select how many loopsto include in the lead circuit depending on where the pacemaker can isplaced in the body and the length of the lead. In this alternativeembodiment, the present invention monitors the voltages on thepacemaker's lead(s) and selects a different number of loops to connectto the lead(s) to cancel any induced voltages. Lastly, the selectionmechanism may be externally programmed and transmitted to thepacemaker's PLU that then monitors and adjusts the number of loops inthe lead circuit.

FIG. 10 is a schematic of a pacemaker system 300 that includes apacemaker canister 302 and the pacemaker's leads 304. The pacemaker'scanister 302 contains a programmable logic unit (PLU) 306, and otherelectronics 310, e.g. a pulse generator, power supply, etc. The system300 further includes conductive loops 308 positioned within thepacemaker canister 302.

The conductive loops are connected to a loop selection component 312that provides means for selectively adjusting the number of loops to beincluded in the leads' circuit 304. The leads 304 are also connected tothe loop selection component 312 so that the leads 304 can beelectrically connected to the loops 308.

The loop selection component 312 connects the loops 308 to the leads'circuit 304 in such a way that any induced voltages in the loops 308caused by changing magnetic fields in the environment, e.g. an magneticresonance imaging environment, will cancel out or significantly reducein magnitude any induced voltage along the leads 304 that have also beencaused by the environment's changing magnetic fields.

In one embodiment, the loop selection component 312 is adjusted manuallyby screws, connection pins, and/or other means.

In another embodiment, the loop selection component 312 is controlled bythe PLU 306. The PLU 306 may include means for receiving loop selectioninstructions from an external transmitter or may include sensors thatmeasure environmental variables, e.g. changing magnetic fields in anmagnetic-resonance imaging environment. From this information, the PLU306 dynamically adjusts the loop selection component's 312 adjustableparameters so as to change which loops are included in the leads'circuitry 304.

It is noted that the loops 308 need not be all in the same plane.

FIG. 11 is a schematic of another pacemaker system 320. Pacemaker system320 includes conductive loops 322 positioned externally to a pacemakercanister 302. In this embodiment, the loops 332 are connected to aninput port connection 330 and to an output port connection 334 which areelectrically connected to the loop selection component 324 locatedinside the pacemaker canister 302. Additionally, the pacemaker leads 304are connected to an electrical connector 332 that is electricallyconnected to the loop selection component 324. It is noted that theconductive loops 322 need not be all in the same plane.

FIG. 12 depicts a medical procedure in which a catheter 406 or othermedical device, e.g. a guidewire, which is comprised of conductive leadsor other conductive components, may be partially inserted into a body402 and partially external to the body. In an magnetic-resonance imagingenvironment, such conductive medical devices 406 can develop problemslike heating, induced voltages, etc. caused by the changing magneticfields of the magnetic-resonance imaging system. To compensate forinduced currents and/or induced voltages in such devices 406, a voltagecompensation unit (VCU) 410 is electrically connected to the medicaldevice 406 via conductive leads 412 and electrical connectors 414,externally to the patient's body 402.

The medical device 406 is constructed with additional electricalconnectors 414 to allow for easy attachment of the VCU device 410. TheVCU device 410 is connected to a power supply or may have a built inpower supply, e.g. batteries. The VCU device 410 has sensors built intoit, which monitor the voltages of the conductive components in themedical device 406, and delivers opposing voltages to the medical device406 to cancel out or significantly reduce any induced voltages caused bythe changing magnetic fields in an magnetic resonance imaging (or other)environment.

Additionally or alternatively, the VCU device 410 has sensors to detectthe changing magnetic fields of the magnetic-resonance imaging systemand can synchronize the application of the canceling voltage with themagnetic-resonance imaging System's changing fields.

In another embodiment depicted in FIG. 13, the VCU device 420 isconnected to the magnetic-resonance imaging system 422 via communicationmeans 424 so that the start and end of the application of themagnetic-resonance imaging system's 422 fields may be communicated tothe VCU device 420. Other information that may be required (fieldstrengths to be applied, magnetic resonance imaging scan sequence, etc.)may also be communicated to the VCU device 420. The communication means424 may be electrical wires/coaxial/shielded/other, optical fiber, or anRF transmitter/receiver, or some sonic means of communication.

The conductive lead of a heart pacemaker is a filer winding. The filerwinding may consist of two or more conductive stands coiled together ina spring-like configuration. The current (pulses, signals) then flowsover the surface and through the contact points between one loop and theadjacent loop of the winding, rather than following the windings of theindividual conductive strands. This occurs because there is nosignificant insulating material or surface coating between the contactpoints of the windings.

In accordance with the present invention, to reduce the alternating,induced current flowing, caused by a magnetic resonance system'schanging magnetic fields, through the, for example, pacemaker's windingleads, the inductance value of the pacemaker's lead may be changed toincrease the overall impedance of the pacemaker's lead.

Thus in one embodiment, a suitable RF choke is inserted inline with thepacemaker's lead, preferable near the distal tip. For example, referringback to FIG. 2, and to the embodiment therein, electronic component 146and/or 144 may comprise an RF choke. In a preferred embodiment, the RFchoke has an inductance value of about 10 microHenries. In anotherembodiment, the inductance value is about 2 microHenries.

The specific value of inductance to introduce into the, for example,pacemaker's lead depends in part on the frequency of the induced signalfrom the magnetic-resonance imaging system's imaging sequence that is tobe blocked or significantly reduced.

FIG. 14 shows a portion of a coiled multi-filer lead 450. As illustratedin FIG. 14, lead 450 includes a plurality of coil loops 452; each coilloop 452 consists of three conductive strands 454, 456, and 458. Acurrent 460 through the lead 450 can cross contact points 464, 466, and462 between the strands as well as the coil contact points 468 and 470.Thus, the current 460 does not follow the coiling of the lead'sconductive strands 454, 456, and 458.

FIG. 15 shows a portion of a coiled lead assembly 480 including a region482 that has an insulating coating 484 applied to its surface. Thecoiled lead assembly 480 is depicted in an elongated position in whichadjacent coil windings are not in contact with one another. It is to beunderstood that the normal, relaxed position of the lead assembly 480has all adjacent coiled windings in contact.

With the addition of an insulated coating 484 over the winding region482, the current 490, 492, and 494 is now forced to substantially followthe curvature of the coiled winding 482, thus forming an inductive coilinline with the conductive lead regions 486 and 488 which do not have aninsulated coating. The inductive value of the created inductor can beadjusted by adjusting the length of the region to which the insulativecoating 484 is applied.

It is noted that the coating 484 may be a partially resistive material.In such an example, the inductance is then adjusted by adjusting theresistive properties of the material 484.

FIG. 16 is a schematic of a coiled lead assembly 500 comprised ofuninsulated regions 502, 504, and 506, and coated insulated regions 508and 510 with coatings 512, and 514, respectively. Through theapplication of the coating, the current is forced to substantiallyfollow the curvature of the coiled windings, thus forming an inductivecoil inline with the conductive lead regions that do not have a coatingapplied thereto. The inductive value of the created inductor can beadjusted by adjusting the length of the region to which the insulativecoatings 512 and 514 are applied. In one embodiment, coatings 512 and514 are the same coatings. In another embodiment, the coatings 512 and514 are different materials.

It is noted that coatings 512 and 514 may be the same coating materialbut having differing properties, e.g., the thickness of the coatings, orthe length of the coated region 508 and 510. It is further noted thatthe two-coated regions 508 and 510 may have different inductive values.It is also noted that more than two different regions along the lengthof the lead assembly can be coated.

FIG. 17 is a schematic of a portion of a coiled lead assembly 520including at least one region 524 with a coating applied thereto.Through the application of the coating, the current is forced tosubstantially follow the curvature of the coiled windings, thus formingan inductive coil inline with the conductive lead regions 522 and 526that do not have a coating applied thereto.

The inductive value of the created inductor can be adjusted by adjustingthe length of the region to which the insulative coating 524 is applied.Additionally, through the coated region 524 is positioned a rod 528which also changes the inductive value of the coated region 524. It isnoted that the rod 528 may be of ferrite material. It is further notedthat multiple rods can be inserted into multiple coated regions alongthe length of the coiled lead.

It is noted that multiple coatings can be applied to the same coatedregion of the coiled lead wherein the multiple coating layers may becomprised of different materials. It is further noted that one or morelayers of the multiple layers of coatings may comprise ferrite material.

In another embodiment of the present invention, the heating and/orinduced voltages on catheters or guide wires is controlled orsubstantially eliminated by introducing or creating detunedcharacteristic impedance at a proximal ends (ends that are not withinthe body) of the catheters or guide wires. This introduction or creationof detuned characteristic impedance will be discussed in more detailwith respect to FIGS. 18-21.

As noted above, during magnetic-resonance imaging procedures, catheters,and guide wires (wire lines), with or without grounded shielding, areused to measure physiological signals. In such instances, two-wirecatheters or guide wires having a grounded shield have one conductorthat carries the actual measured signal and the other wire is grounded.In terms of characteristic impedance, the two-wire catheters or guidewires having a grounded shield are unbalanced. In contrast, a singlewire catheter or guide wire has characteristic impedance that isbalanced.

According to the concepts of the present invention, the characteristicimpedance of the catheters and guide wires, used duringmagnetic-resonance imaging procedures, should be unbalanced at theproximal end, under all conditions, to reduce or eliminate heating andinduced voltages. To realize this reduction or elimination of heatingand induced voltages at the proximal end of the catheters and guidewires, used during magnetic-resonance imaging procedures, by creating anunbalanced characteristic impedance, the present invention proposesproviding a Balun along the catheter and/or guide wire or at theproximal end of the catheter and/or guide wire.

Using a Balun to maintain unbalanced characteristic impedance, thereactance at the distal end of the catheter and/or guide wire approachesinfinity. Thus, even when there is some potential on the wire, theunbalanced characteristic impedance has approximately four times theground loop looses of a balanced line, thereby substantially avoidingany incident of thermal injury. An example of such an arrangement isillustrated in FIG. 18.

As illustrated in FIG. 18, a guide wire or catheter 650 hascharacteristic impedance due to its intrinsic resistance from intrinsicresistor capacitors RP and its intrinsic inductance from intrinsicinductor L. To create the unbalanced characteristic impedance at theproximal end of the guide wire or catheter 650, a Balun 600 is placedalong the guide wire or catheter 650. In other words, the Balun 600 isin vitro.

The Balun 600 includes a variable capacitor C1 connected in parallelwith the guide wire or catheter 650 and two variable capacitors C2 andC3 connected in series with the guide wire or catheter 650. It is notedthat one end of the variable capacitor C2 is connected to the shield 625and ground or a known voltage. The capacitance of the variablecapacitors C1, C2, and C3 are adjusted to create the unbalancedcharacteristic impedance.

More specifically, the variable capacitors C1, C2, and C3 may be usedfor both matching and providing a certain amount of balancing for theguide wire or catheter characteristic impedance. In this example, thevariable capacitors C1, C2, and C3 lift the voltage on the guide wire orcatheter 650 from ground. The larger the reactance of the variablecapacitors C1, C2, and C3, the more symmetric and balanced the circuitof the guide wire or catheter 650 becomes.

Conversely, according to the concepts of the present invention, if thereactive capacitance of the Balun 600 is detuned (made less resonant),the circuit of the guide wire or catheter 650 becomes asymmetric andunbalanced, breaking down, to reduce the chances of thermal injury atthe distal end of the guide wire or catheter 650 due to heating frominduced voltages.

FIG. 19 illustrates another embodiment of the present invention whereina guide wire or catheter 6500 has characteristic impedance due to itsintrinsic capacitance from intrinsic capacitors Ct and Cs and itsintrinsic inductance from intrinsic inductor L. To create the unbalancedcharacteristic impedance at the proximal end of the guide wire orcatheter 6500, a Balun 6000 is connected across the proximal end of theguide wire or catheter 6500. In other words, the Balun 6000 is outsidethe body at the proximal end of the guide wire or catheter 650. Byhaving the Balun 6000 outside the body, the varying of the reactance ofthe guide wire or catheter 6500 can be readily and manually controlled.

The Balun 6000 includes a variable capacitor C1 connected in parallelwith the guide wire or catheter 6500 and a variable capacitor C2connected in series with the guide wire or catheter 6500. It is notedthat one end of the variable capacitor C1 is connected to the shield6250 and ground or a known voltage. The capacitance of the variablecapacitors C1 and C2 are adjusted to create the unbalancedcharacteristic impedance.

More specifically, the variable capacitors C1, and C2 may be used forboth matching and providing a certain amount of balancing for the guidewire or catheter 6500 characteristic impedance. In this example, thevariable capacitors C1, C2, and C3 lift the voltage on the guide wire orcatheter 6500 from ground. The larger the reactance of the variablecapacitors C1 and C2, the more symmetric and balanced the circuit of theguide wire or catheter 6500 becomes.

Conversely, according to the concepts of the present invention, if thereactive capacitance of the Balun 6000 is detuned (made less resonant),the circuit of the guide wire or catheter 6500 becomes asymmetric andunbalanced, breaking down, to reduce the chances of thermal injury atthe distal end of the guide wire or catheter 6500 due to heating frominduced voltages.

FIG. 20 illustrates a further embodiment of the present inventionwherein a guide wire or catheter 8000 is connected to a Balun 7000. TheBalun 7000 includes a variable capacitor 7100, a copper foil 7200, and anon-conductive tuning bolt 7300. The Balun 7000 is further connected tothe output of the probe 8000.

The Balun 7000 adjusts its characteristic impedance by increasing ordecreasing the number wire coils are found within the copper foil 7200.The combination of the coils and the copper foil 7200 forms a variablecapacitor, having it impedance determined by the change in the surfacearea of the coils positioned opposite of the copper foil 7200. As morecoils are introduced into the volume created by the copper foil 7200,the capacitance of this combination increases. Moreover, as fewer coilsare introduced into the volume created by the copper foil 7200, thecapacitance of this combination decreases. Thus, the capacitance of theBalun 7000 is adjusted to create the unbalanced characteristicimpedance.

FIG. 21 illustrates another embodiment of the present invention whereina guide wire or catheter 900 is electronically isolated by a voltagecontrol unit to always appear as an unbalanced line to any possiblemagnetic field that may be applied from a magnetic resonance imager unit(not shown). As current begins to flow due to the changing magneticfields from the magnetic resonance imaging, a tapped voltage from avoltage-controlled oscillator in the magnetic resonance imaging unit isapplied across terminals X1 and X2 of the voltage control unit.

According to the concepts of the present invention, to automaticallymaintain an unbalanced characteristic impedance at the distal end of theguide wire or catheter 900, a capacitance unbalanced balun unit 7000,located within the voltage control unit, is connected through a variableinductor 910 to the proximal end of the guide wire or catheter 900. Inother words, the voltage control unit containing the capacitanceunbalanced balun unit 7000 is outside the body at the proximal end ofthe guide wire or catheter 900. By having the capacitance unbalancedbalun unit 7000 and variable inductor 910 outside the body, the varyingof the reactance (X0) of the guide wire or catheter 900 can be readilyadjusted and automatically controlled by the voltage control unitcircuit's reactance to the tapped voltage from the voltage-controlledoscillator in the magnetic resonance imaging unit as it is appliedacross X1 and X2 for any instance of time from time zero (T0) orinstantiation of the magnetic resonance imaging radio-frequency pulses.

The capacitance unbalanced balun unit 7000 includes two nonmagnetictrimmer capacitors C1 and C2 connected in parallel with LC circuits(L1,C3) and (L2,C4), respectively, setting up a simplified dual Tnetwork that is effectively in series with the guide wire or catheter900. It is noted that one end of the simplified dual T network isconnected to neutral H1 and the other end is connected to a continuouslyvariable voltage H2, based on inputs to the circuit from thevoltage-controlled oscillator in the magnetic resonance imaging unit atX1 and X2. The reactance (X0) of the LC circuits in the T network isautomatically adjusted to create the desired unbalanced characteristicimpedance.

More specifically, the T network L1, C1, C3 and L2, C2, C4 respectively,may be used for both matching and unmatching characteristic impedance ofthe guide wire or catheter 900 and to provide a certain amount ofbalancing or unbalancing for the guide wire or catheter 900 by varyingthe circuit's capacitive or inductive reactance (X0).

In this example, as the voltage from the voltage-controlled oscillatorin the magnetic resonance imaging unit is provided to the voltagecontrol unit (X1 X2), the two non-magnetic trimmer capacitors C1 and C2,connected in parallel with LC circuits, (L1,C3) and (L2,C4), lift thevoltage on the guide wire or catheter 900 from ground to an unbalancedstate with respect to the radio-frequency pulse applied by the magneticresonance imaging unit. The reactance of the T network and its LCcircuits, (L1,C3) and (L2,C4), respectively, cause the guide wire orcatheter 900 to become asymmetric and unbalanced, automatically breakingdown the reactance to ensure that resonance for the guide wire orcatheter 900 is never present, thus reducing the chances of thermalinjury at the distal end of the guide wire or catheter 900 due toheating from induced voltages.

As noted above, a lead implanted into a biological body; e.g. a pacinglead, or a deep brain stimulation lead; is a source of potentiallyharmful effects to the biological body when submitted to a magneticresonance imaging examination. These harmful effects include: 1) heatingof the tissue in contact with the lead's stimulation and/or senseelectrodes due to the magnetic resonance imaging scanner's so calledradio frequency (or B1) field; and/or 2) improper stimulation of tissuedue to induced voltages across the biological body's tissue and thelead's electrodes caused by the various changing magnetic fieldsproduced by the magnetic resonance imaging scanner including theswitched gradient fields and the radio frequency field.

To overcome or mitigate these harmful effects, various frequencydependent filters including resonant circuits (tank circuits) and/orhigh pass filters have been used. These circuits require the circuitcomponents to have certain values so as to be tuned to certainfrequencies.

It would be preferable to reduce or eliminate these harmful effects tothe biological body by inserting non-frequency dependent circuits and/orcircuit elements inline with at least some of the lead's conductors. Thenon-frequency dependent circuits block or reduce at least a portion ofthe induced currents and/or voltages in the lead or at the lead tissueinterface, caused by the changing magnetic fields of the magneticresonance imaging scanner.

The heating of tissue near a conductive electrode is essentially causedby a current passing through the tissue to or from said electrode.Since, in the simplest case, electrical power which is converted intoheat is related to the second power of the current passing through aresistive material (e.g. tissue), a decrease in the current by ½ willpotentially decrease the amount of harmful tissue heating by ¼.

FIG. 22 depicts an implantable therapeutic system 1000 including anelectronics unit 1100 and a lead assembly 1120. The lead assembly 1120has a proximal region 1140 and a distal region 1160 through which one ormore conductor assemblies 1180 extends from the electronics unit 1100,through the proximal region 1140 and the distal region 1160, to end atan electrode 1200.

The electrode 1200 is in contact with biological tissue (not shown) whenthe therapeutic system 1000 is implanted or partially implanted into abiological body (not shown).

The conductor assembly 1180 includes a conductive wire 1240, a circuitassembly 1220, and connection 1260 to the electrode 1200. In theembodiment depicted in FIG. 22, the circuit assembly 1220 is a diode.The diode 1220 is designed such that a stimulation pulse (not shown)generated in the electronics unit 1100 can travel through the proximalregion 1140, through the diode 1220 in the distal region 1160 to theelectrode 1200, while significantly reducing any the magnetic resonanceimaging scanner induced current from traveling from the electrode 1200through the connector 1260 and through the diode 1220.

In one embodiment conductive wire 1240 is a multi-filar coiled wire. Inanother embodiment conductive wire 1240 is a single filar coiled wire.In another embodiment, conductive wire 1240 is a multi-filar braidedwire.

FIG. 23 is a schematic of an implantable therapeutic system 2000including an electronics unit 2100, a lead assembly 2120 having aproximal region 2140 and a distal region 2160 such that electrodes 2260,2280 are attached to lead assembly 2120 in the distal region 2160.

In one embodiment, the implantable therapeutic system 2000 is a bipolarpacing system. The lead assembly 2120 further includes conductorassemblies 2180 and 2200. Conductor assembly 2180 includes conductor2400, one or more electronic elements 2220, and connection 2300 toelectrode 2260. Conductor assembly 2200 includes conductor 2420, one ormore electronic elements 2240, and connection 2320 to electrode 2280.

In one embodiment, electronic elements 2220 and 2240 are diodes. In theembodiment depicted in FIG. 23, the diode 2220 is designed tosubstantially allow a pulse, e.g. a pacing pulse or a stimulation pulse,to propagate from the electronics unit 2100 through the proximal region2140 through conductor 2400 through diode 2220 through connection 2300to the electrode 2260, while substantially reducing any magneticresonance imaging induced current from traversing from the electrode2260 through connection 2300 and through the diode 2220.

Continuing with FIG. 23, the diode 2240 is designed to substantiallyallow a signal; e.g. a sensing signal, to propagate to the electronicsunit 2100 from the electrode 2280 through the proximal region 2240,conductor 2200, diode 2240, and connection 2320, while substantiallyreducing or blocking magnetic resonance imaging induced current fromtraveling to the electrode 2280 through connection 2320 and through thediode 2240.

FIG. 24 depicts an implantable therapeutic system 3000 including anelectronics unit 3100 and a lead assembly 3120. The lead assembly 3120has a proximal region 3140 and a distal region 3160 and through whichone or more conductor assemblies 3180 extends from the electronics unit3100 through to end at an electrode 3240. The electrode 3240 is incontact with biological tissue (not shown) when the therapeutic system3000 is implanted or partially implanted into a biological body (notshown).

The conductor assembly 3180 includes a conductive wire 3240, a circuitassembly 3300, and connection 3280 to the electrode 3240. In theembodiment depicted in FIG. 24, the circuit assembly 3300 comprises aZener diode 3200 and a diode 3220. The diodes 3200 and 3220 are orientedsuch that a stimulation pulse (not shown) generated in the electronicsunit 3100 can travel through the proximal region 3140 along conductivewire 3240, through the Zener diode 3200, connection 3260, through thediode 3220, and through the connection 3280 to the electrode 3240, whilesignificantly reducing any magnetic resonance imaging scanner inducedcurrent from traveling from the electrode 3240 through the connector3280 and through the circuit assembly 3300.

In one embodiment, the stimulation pulse is a pacing voltage pulse. Inanother embodiment, the pacing pulse is greater than 4 Volts, while thereverse bias voltage (also called the backward breakdown voltage) of theZener diode 3200 is sufficiently less than 4 volts to allow the pacingpulse to propagate through the Zener diode 3200 while blocking any otherinduced voltage signals that are less than 4 Volts. In one embodiment,the backward bias voltage is approximately 3 Volts.

Other types of diodes such as tunneling or Schottky diodes could be usedalone or in combinations with these or other diodes or circuits toreduce the induced currents and/or voltages due to the magneticresonance imaging scanner while not substantially altering the currentsand/or voltages of the implanted or partially implanted therapeuticsystem.

In another embodiment, diodes are placed in series with filters, such asone or more resonant (tank) circuits, one or more notch filters, one ormore high pass filters, etc. or combinations to reduce the inducedcurrents due to the magnetic resonance imaging scanner's changingmagnetic field while not significantly altering the voltages and/orcurrents generated by the implanted (or partially implanted) therapeuticsystem.

It is to be understood that the therapeutic systems depicted includingan electronic unit and one or more lead assemblies are such that thelead assemblies are detachable from the electronic unit. In otherembodiments, the lead assemblies are not detachable from the electronicsunit. In still other embodiments, some of the lead assemblies aredetachable and some are not detachable from the electronics unit.

It is to be understood that the diode symbols used in the Figures arenot necessarily indicative of the diode type to be used. That is, insome Figures, the type of diode indicated in the Figure is not the typeof diode to be utilized. FIG. 25 is a graph of one potential type oftherapeutic voltage pulse. In one case, this may be a pacing pulse. Inthis graph, the voltage pulse has a positive voltage region 402 and anegative voltage region 404. The negative region is substantially lessin magnitude, but the area under the positive voltage region 402 issubstantially equal to the area under the negative voltage region 404.In some situations, the negative region 404 may be longer in durationthan the duration of the positive region 402.

It is to be understood that the shape of the pulse in FIG. 25 is anidealization to the actual pulse applied. That is, the actual pulse willbe a more rounded shape than the sharp corners depicted. In someapplications, the rise and fall times of the pulse will be significantlylonger than that depicted. Additionally, the real therapeutic voltagepulse will have some small fluctuations due to environmentalelectromagnetic noise.

In some applications, the negative region is essentially zero voltage.In another application, the negative region fluctuates around zerovoltages. In another application, the fluctuations around zero voltagesare due to electromagnetic noise in the environment.

FIG. 26 is a graph 500 of a diode's Current versus Voltage performanceof a Zener type diode. The diode has a forward bias voltage thresholdVf, as illustrated in FIG. 26. A voltage 504 greater than the forwardbias voltage applied to the diode in the forward direction allowscurrent to pass through the diode 502.

The diode also has a backward bias (also known as a break down) voltage(Vb in FIG. 26). A voltage greater 506 than the breakdown voltageapplied in the backward direction will cause the diode to break down andallow significant current through the diode in the backward direction.Voltages less than the break down voltage applied in the backwarddirection will result in very little to no current 510 to flow throughthe diode in the backward direction.

From zero voltage to the breakdown voltage, there is a current leakageregion 508 where there is the possibility of a leak current to passthrough the diode in the backward direction. The magnitude of theforward bias voltage threshold Vf is less than the magnitude of thebreakdown voltage Vb.

It is desirable to adjust the forward bias voltage threshold, the breakdown voltage threshold, and the current leakage threshold regionparameters of the diode such that the therapeutic stimulation voltagepulse characteristics described in FIG. 25 can pass through the diode.That is, the breakdown voltage 506 of FIG. 26 is less than the voltage402 of the therapeutic pulse of FIG. 25 and the leakage region 508 ofFIG. 26 of the diode is sufficiently large to allow the negative voltage404 of FIG. 25 to pass through the diode.

In another embodiment, the leakage region threshold is essentially zerovolts, such that there is essentially no current flow through the diodein the backward direction for voltages applied in the backward directionuntil the voltage applied in the backward direction approaches thebreakdown voltage threshold.

FIG. 27 depicts an implantable therapeutic system 600 including anelectronics unit 610 and one or more lead assemblies 612. The leadassembly 612 includes a proximal region 614 and a distal region 616. Thedistal region 616 includes a circuit assembly 630 including diodes 620and 622. In one embodiment, diode 620 is a Zener diode. In oneembodiment, proximal region 614 includes circuit assembly 640 includinga diode 642.

In another embodiment, circuit assembly includes diodes and othercircuit elements (for example, inductors, capacitors, resistors.) Inother embodiments, not shown, one or more diodes are positioned alongthe length of the lead assembly.

FIG. 28 depicts an implantable therapeutic system 700 including anelectronics unit 710 and one or more lead assemblies 712. Lead assembly712 includes a proximal region 714 and a distal region 716. Distalregion 716 includes a circuit assembly 730 which includes one of morediodes 722 and one or more circuit assemblies 720. In one embodiment,circuit assembly 720 includes at least one resonant circuit, theresonant circuit including at least one inductor 750 in parallel with atleast one capacitor 752. It is to be understood that the simulationsdescribed below are for illustrative purposes only. Moreover, forcomparison purposes only, the goal of each of the simulations is toproduce 4 volts across the “TipTissue” interface resistor, whilereducing or eliminating other so called “induced” voltages programmedinto the simulations.

FIG. 29 depicts a simulation of an implantable therapeutic system 810including a square wave pulse 802. The square wave pulse generator 802produces an essentially square wave voltage pulse of 4 volts.Implantable therapeutic system 810 further includes a conductive lead820 having a proximal region 814 near the square wave generator 802 anda distal region 812 near the “TipTissue” resistor. The “TipTissue”interface resistor represents the resistance of the tissue in contactwith and adjacent to an electrode in the distal region 812 of theimplantable therapeutic system.

As can be seen in the graph of the voltage, across the “TipTissue” isessentially a square wave pulse 850 having amplitude of 4 volts. FIG. 30is a simulation of an implantable therapeutic system 910. The simulationincludes a tissue interface resistance “TipTisssue” 1000, a stimulationpulse generator Stim1 that provides four volt square wave pulsestimulation to the “TipTissue.” Additionally, there is a sine wavevoltage source 940 representing induced voltages caused by a magneticresonance imaging scanner. The voltage from the sine wave generator 940has amplitude of ˜0.5 volts and a frequency of ˜63.86 megahertz. It isto be understood that the sine wave generator is for modeling andillustrative purposes only.

The graph shows that during the application of the square wave pulse,the voltage across the “TipTissue” resistor is now a combined squarewave plus an oscillating wave 950. The oscillations 960 cause theamplitude of the square wave to oscillate from 4.5 volts to 3.5 volts.At times other than during the application of the square wave pulse,there is a voltage oscillation across the “TipTissue” interface resistor1000. The oscillating voltage has a positive value 954 and a negativevalue 956.

These oscillating voltages across the “TipTissue” interface resistor1000 represent the magnetic resonance imaging induced current throughthe resistive tissue in contact with the electrodes of an implantedtherapeutic system. Such induced currents can produce harmful thermaldamage to the tissue.

FIG. 31 depicts the simulation of an implantable therapeutic system 1010including an electronics unit 1012 producing an essentially square wavevoltage pulse of four volts and a circuit 1014 in the distal end of thetherapeutic system 1010 near the “TipTissue” interface resistor 1000.The circuit 1014 includes a diode 1016. The sine wave generator 1020produces a sine wave with amplitude of 0.5 volts at a frequency of 63.86megahertz.

The graph in FIG. 31 depicts the voltage across the “TipTissue”interface resistor 1000. The resulting pulse 1050 has a sine waveimposed on it resulting in the amplitude of the pulse 1050 beingoscillatory 1056 rather than constant.

Further, at other times before and after the square wave pulse from theelectronics unit 1012, there occurs only the positive portion 1054 ofthe sine wave from the sine wave generator 1020. The diode 1016 blocksthe negative portions of the sine wave, hence significantly reducing theheating that would occur. It is noted that the diode 1016 does not blockthe oscillating voltage during the square wave pulse because the squarewave pulse has already turned the diode 1016 ON.

FIG. 32 depicts the simulation of an implantable therapeutic system 1110including an electronics unit 1112 producing essentially a square wavevoltage pulse of seven volts and a circuit 1114 in the distal end of thetherapeutic system 1110 near the “TipTissue” interface resistor 1000.The circuit 1114 includes diodes 1116 and 1118. Diode 1118 has abackward break down voltage threshold of three volts. The sine wavegenerator 1120 produces a sine wave with amplitude of 0.5 volts at afrequency of 63.86 megahertz.

It is noted that the voltage of the square wave pulse from theelectronics unit 1112 has been increased by the diode's 1118 break downthreshold amount.

The graph of the resulting voltage 1150 across the “TipTissue” 1000 overtime is again four volts from the electronics unit 1112 produced 7 voltsquare wave pulse plus the 0.5 sine wave 1152. At times other thanduring the pulse 1150, the diodes 1116 & 1118 significantly diminish thevoltage 1154 across the “TipTissue” interface resistor 1000, therebyreducing any tissue heating.

FIG. 33 depicts the simulation of an implantable therapeutic system 1210including an electronics unit 1212 producing essentially a square wavevoltage pulse of seven volts and a circuit 1214 in the distal end of thetherapeutic system 1210 near the “TipTissue” interface resistor 1000.The circuit 1214 includes diodes 1216 and 1218 as well as a circuit 1220which includes an inductor 1222 and a capacitor 1224 in parallel to forma resonant circuit 1220.

The inductor's value and the capacitor's value are chosen to make thecircuit 1220 have a resonance at the frequency of the applied sign waveproduced by the sine wave generator 1205. The diode 1216 has a backwardbreak down voltage threshold of three volts. The sine wave generator1205 produces a sine wave with amplitude of 0.5 volts at a frequency of63.86 megahertz.

The graph of the voltage across the “TipTissue” interface resistor 1000shows that, at times other than during the application of the squarewave pulse 1250, there is negligible voltage 1252 across the interfaceresistor 1000.

During the square wave pulse 1250, the pulse has an oscillation 1254 dueto the sine wave generator's voltage. It is seen that the amplitude ofthe sine wave component of the square wave pulse over time 1260 andlater 1262 is diminished due to the resonant circuit 1220.

FIG. 34 depicts the simulation of an implantable therapeutic system 1310including an electronics unit 1312 producing essentially a square wavevoltage pulse of four volts and a circuit 1314 in the distal end of thetherapeutic system 1310 near the “TipTissue” interface resistor 1000.The circuit 1314 includes diode 1316 as well as a circuit 1318 whichincludes an inductor 1320 and a capacitor 1322 in parallel to form aresonant circuit 1318.

The inductor's value and the capacitor's value are chosen to make thecircuit 1318 have a resonance at the frequency of the applied sign waveproduced by the sine wave generator 1330. The sine wave generator 1330produces amplitude of 0.5 volts at a frequency of 63.86 megahertz.

It is seen from the graph of the voltage across the “TipTissue” resistor1000 that the sine wave oscillations are diminished in amplitude 1356 &1358 during the application of the square wave pulse 1350. At othertimes, the sine wave is reduced to half a sine wave 1352 by the diode1316. Additionally, the amplitude of the half-sine wave after the squarewave pulse 1350 is significantly diminished 1360 & 1362 compared to anearlier time 1352. The diminishing of the sine wave oscillations is dueto the resonant circuit 1318.

FIG. 35 depicts the simulation of an implantable therapeutic system 1410including an electronics unit 1412 producing essentially a square wavevoltage pulse of four volts. The simulation depicted further includes asine wave generator 1420 producing a sine wave with amplitude of 0.5volts at a frequency of 63.86 megahertz. The sine wave generator isturned OFF after a short period of time 1456.

A pulse generation system 1422 includes two pulse generators 1424 and1426. Each of these pulse generators 1424, 1426 generates a 3.5 voltpulse. The sign of the voltage pulse from 1424 is opposite to the signof the pulse from 1426. The two pulse generators represent, for example,a magnetic resonance imaging scanner's gradient field being turned ONand OFF.

The graph of the voltage across the “TipTissue” interface resistor 1000shows the sine wave 1454, the square wave 1450 having an oscillatingamplitude 1452, and the time 1456 at which the sign wave is turned OFF.At a later time the first gradient induce voltage 1458 is applied andstill later the second gradient induced pulse 1460 is applied.

FIG. 36 depicts the simulation of an implantable therapeutic system 1510including an electronics unit 1512 producing essentially a square wavevoltage pulse of seven volts and a circuit 1514 in the distal end of thetherapeutic system 1510 near the “TipTissue” interface resistor 1000.The circuit 1514 includes diodes 1516 and 1518. Diode 1516 has abackward break down voltage threshold of three volts. The sine wavegenerator 1520 produces a sine wave with amplitude of 0.5 volts at afrequency of 63.86 megahertz. The sine wave generator is turned OFFafter the square wave pulse.

A pulse generation system 1522 includes two pulse generators 1524 and1526. Each of these pulse generators 1524 & 1526 generates a 3.5 voltpulse. The sign of the voltage pulse from 1524 is opposite to the signof the pulse from 1526. The two pulse generators represent, for example,a magnetic resonance imaging scanner's gradient field being turned ONand OFF.

The voltage across the “TipTissue” interface resistor 1000 isessentially that of the square wave pulse 1550 with a small oscillation1552. At times other than during the square wave voltage pulse, the sinewave is essentially eliminated 1554 by the two diodes 1516 & 1518. Thegradient induced voltage pulses at times 1558 and 1556 are alsoessentially eliminated. At time 1556, the gradient voltage pulse isreduced from 3.5 volts to 0.5 volts due to the break down voltage ofdiode 1516 being 3.0 volts.

Such reductions to the gradient induced voltages essentially eliminateany harm to the patient into which the therapeutic system has beenimplanted due to the gradient induced voltages.

While various examples and embodiments of the present invention havebeen shown and described, it will be appreciated by those skilled in theart that the spirit and scope of the present invention are not limitedto the specific description and drawings herein, but extend to variousmodifications and changes.

What is claimed is:
 1. An elongate lead assembly configured tooperatively couple with an implantable medical device for delivering atherapy pulse from the implantable medical device to a patient in anenvironment of a changing magnetic field, the lead assembly comprising:a conductive wire having a proximal end proximate the implantablemedical device and a distal end opposite the proximal end; an electrodecoupled proximate the distal end of the conductive wire and configuredto deliver the therapy pulse to the patient; and an electrical circuitoperatively coupled to the conductive wire, wherein the electricalcircuit is configured to: pass current in a first direction from theproximal end to the distal end of the conductive wire when a firstvoltage having a magnitude above a first voltage threshold is appliedacross the electrical circuit in the first direction positively biasingthe electrical circuit in the first direction by the changing magneticfield; and pass current in a second direction opposite the firstdirection when a second voltage having a magnitude above a secondvoltage threshold is applied across the electrical circuit in the seconddirection by the changing magnetic field but substantially blockingcurrent in the second direction when a voltage less than the secondvoltage threshold is applied across the electrical circuit in the seconddirection negatively biasing the electrical circuit in the firstdirection by the changing magnetic field.
 2. A lead assembly accordingto claim 1 wherein the electrical circuit is a first electrical circuitand further comprising a second electrical circuit coupled in serieswith the electrical circuit and the first electrode, the secondelectrical circuit configured to substantially block current flowing inthe second direction and pass current flowing in the first direction. 3.A lead assembly according to claim 2 further comprising a thirdelectrical circuit coupled at the proximal end of the conductive wireand in series with the first and second electrical circuits, the thirdelectrical circuit configured to substantially block current flowing inthe second direction and pass current flowing in the first direction. 4.A lead assembly according to claim 1 wherein the medical device receivesa sensing signal, wherein the conductive wire is a first conductive wireand the electrode is a first electrode and wherein the lead assemblyfurther comprises: a second conductive wire having a proximal endproximate the implantable medical device and a distal end opposite theproximal end; a second electrode coupled proximate the distal end of thesecond conductive wire; and a fourth electrical circuit coupled inseries with the second conductive wire and the second electrode, thefourth configured to pass the sensing pulse from the distal end to theproximal end of the second conductive wire and block a current inducedfrom the proximal end to the distal end of the second conductive wire bythe changing magnetic field.
 5. The lead assembly according to claim 1wherein the electrical circuit is configured to pass the therapy pulsefrom the implantable medical device to the electrode.
 6. The leadassembly according to claim 1 wherein the magnitude of the first voltagethreshold is less than the magnitude of the second voltage threshold. 7.The lead assembly according to claim 1 wherein the magnitude of thesecond voltage threshold is less than the voltage of the therapeuticpulse.
 8. An elongate lead assembly configured to operatively couplewith an implantable medical device for delivering a therapy pulse fromthe implantable medical device to a patient in an environment of achanging magnetic field, the lead assembly comprising: a conductive wirehaving a proximal end proximate the implantable medical device and adistal end opposite the proximal end; an electrode coupled proximate thedistal end of the conductive wire and configured to deliver the therapypulse to the patient; and a Zener diode operatively coupled to theconductive wire, wherein the Zener diode is configured to: pass currentin a first direction from the proximal end to the distal end of theconductive wire when a first voltage having a magnitude above a firstvoltage threshold is applied across the Zener diode in the firstdirection positively biasing the Zener diode in the first direction bythe changing magnetic field; and pass current in a second directionopposite the first direction when a second voltage having a magnitudeabove a second voltage threshold is applied across the Zener diode inthe second direction by the changing magnetic field but substantiallyblocking current in the second direction when a voltage less than thesecond voltage threshold is applied across the Zener diode in the seconddirection negatively biasing the Zener diode in the first direction bythe changing magnetic field.
 9. A lead assembly according to claim 8,further comprising a diode coupled in series with the Zener diode andthe first electrode, the diode configured to substantially block currentflowing in the second direction and pass current flowing in the firstdirection.
 10. A lead assembly according to claim 9 wherein the diode isa first diode and further comprising a second diode coupled at theproximal end of the conductive wire and in series with the Zener diodeand the first diode, the second diode being configured to substantiallyblock current flowing in the second direction and pass current flowingin the first direction.
 11. The lead assembly according to claim 8wherein the Zener diode is configured to pass the therapy pulse from theimplantable medical device to the electrode.
 12. The lead assemblyaccording to claim 8 wherein the magnitude of the first voltagethreshold is less than the magnitude of the second voltage threshold.13. The lead assembly according to claim 8 wherein the magnitude of thesecond voltage threshold is less than the voltage of the therapeuticpulse.